With 10+ years of expertise, uBriGene delivers high-quality, tailored plasmid production services, driving innovation in the biopharma industry.
uBriGene has extensive experience in plasmid DNA production and development, delivering high-quality plasmid preparation services tailored to meet customer needs. Our expertise also extends to patented AAV and LVV helper and packaging plasmids, plasmid cloning and expression, and CRISPR plasmids for precise gene editing.
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Extensive plasmid DNA production experience, delivering high quality while remaining cost-effective.
Plasmid vector construction begins with inserting a gene fragment into a vector backbone. Depending on the application, the plasmid elements can vary significantly, including prokaryotic expression, eukaryotic expression, viral vector packaging, etc. uBriGene’s plasmid construction experts provide full support for molecular cloning.
For discovery research, small-scale plasmid DNA preparation can be performed using commercial plasmid prep kits. For GMP plasmid manufacturing, cell banking is required after plasmid transformation. Fermentation is conducted in a well-controlled fermenter, and high-quality plasmids are then purified using chromatographic methods.
Plasmid development and production diagram.
Agarose gel image of eluted plasmids shows a high percentage of supercoiled forms.
Explore uBriGene’s robust GMP plasmid manufacturing process and testing capabilities.
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In genetic engineering, plasmids are often used as vectors to transport genes of interest into target cells. Apart from their widespread applications in the field of scientific research, plasmids are also extensively employed in the development and production stages of various biopharmaceutical products, including recombinant protein drugs, vaccines, gene therapy drugs, CAR-T, and other therapy programs.
We provide flexible plasmid production scales, ranging from microgram (mg) quantities for research purposes to gram (g) quantities for clinical or industrial applications. Our team can help you choose the appropriate scale based on your project’s goals and stage of development.
The timeline for plasmid construction and production depends on the complexity and scale of the project. Research-grade plasmid production typically takes 2-3 weeks, while GMP plasmid production may take 8-12 weeks, depending on the requirements.
We implement stringent quality control (QC) measures throughout the plasmid production process, including DNA sequencing, restriction enzyme analysis, and endotoxin testing (upon request). A full suite of in-house plasmid QC release testing is available for plasmid DNA production. Each batch is produced under the same conditions to ensure consistency.
Yes, our regulatory affairs (RA) team provides support with regulatory documentation and compliance, assisting with submissions to agencies for plasmids intended for clinical use.
Our scaling process involves optimizing and validating the plasmid production method in a process development setting, followed by the implementation of GMP production protocols, including master cell banking, fermentation in controlled fermenters, and chromatographic purification to ensure high quality and regulatory compliance.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
Extensive plasmid DNA production experience
Optimized plasmid preparation processes for high quality and high yield
100+ annual GMP plasmid production batches
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
